Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Chronic Knee Pain
研究概览
简要总结
Knee osteoarthritis has a very high prevalence in the population over 50 years of age. Patients with osteoarthritis often suffer from chronic pain that becomes disabling, affecting both quality of life and mental and physical health. This pathology has also been linked to maladaptive plasticity in the brain, which can contribute to chronic pain. Therapies with neuromodulatory approaches, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (TENS), have been used therapeutically to counteract the maladaptive plasticity of the brain.
Transcranial therapy and TENS can be a possible effective treatment in the rehabilitation services of the health system for the improvement of chronic pain and quality of life in different pathologies, such as chronic low back pain, fibromyalgia or knee and hip osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over fifty years of age with a diagnosis of knee osteoarthritis by radiography.
- •Chronic pain of more than six months, compliance with the diagnostic criteria for knee osteoarthritis according to the Osteoarthritis Research Society International (OARSI) guideline:
- •Pain in Analog Visual Scale more than 4/10
- •Matutinal less than 30 minutes
- •Absence of hyperthermia upon palpation in the joint
- •Alteration of the bone image
排除标准
- •Patients who can provide low-quality or biased information discriminated by the Mini-Mental State Examination (Score less than 24).
- •Severe hearing, visual or sensory impairment or comorbidities that prevent the correct completion of the questionnaires and mobility activities.
- •Patients who have undergone knee replacement surgery on the contralateral knee.
- •Patients who have received intervention (infiltration, blockages, etc...) in the last 6 weeks.
- •Pain due to tendinopathy, knee fracture, low back pain radiating to the knee, or fibromyalgia.
- •Patients who decline to participate out of fear or denial of therapy.
- •Severe heart disease that prevent exercise.
- •Body Mass Index above
- •Patients with neuropsychiatric disorders (schizophrenia, epilepsy or bipolar disorders) or taking medication for these conditions (antiepileptic drugs).
- •Patients with metallic implants in the area (skull or knee).
结局指标
主要结局
Chronic Knee Pain
时间窗: Through study completion, an average of 1 year.
The Visual Analogic Scale will be used to assess the impact on chronic knee pain. The values range from 0 to 10 (0 = No pain, 10 = the worst pain).
次要结局
- Coordination and Balance(Through study completion, an average of 1 year.)
- Function and Quality of Life(Through study completion, an average of 1 year.)
- Force(Through study completion, an average of 1 year.)
- Balance(Through study completion, an average of 1 year.)
- Gait properties.(Through study completion, an average of 1 year.)
- Central Sensitization(Through study completion, an average of 1 year.)
- Kinesiophobia(Through study completion, an average of 1 year.)
- Uncertainly(Through study completion, an average of 1 year.)
- Catastrophizing(Through study completion, an average of 1 year.)